FDA — authorised 28 April 2017
- Application: NDA208743
- Marketing authorisation holder: RADIUS
- Local brand name: TYMLOS
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Tymlos in United States
FDA authorised Tymlos on 28 April 2017
Marketing authorisations
FDA
- Status: approved
Tymlos in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in United States
Frequently asked questions
Is Tymlos approved in United States?
Yes. FDA authorised it on 28 April 2017; FDA has authorised it.
Who is the marketing authorisation holder for Tymlos in United States?
RADIUS holds the US marketing authorisation.